Conference Report

Pharmaceutical Research

, Volume 22, Issue 4, pp 499-511

First online:

Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report

  • Jean W. LeeAffiliated withMDS Pharma Services Email author 
  • , Russ S. WeinerAffiliated withBristol-Myers Squibb
  • , Jeff M. SailstadAffiliated withTrimeris Inc.
  • , Ronald R. BowsherAffiliated withLINCO Diagnostic Services
  • , Dean W. KnuthAffiliated withJasper Clinic
  • , Peter J. O’BrienAffiliated withEli Lilly and Company
  • , Jean L. FourcroyAffiliated withWalter Reed Army Hospital
  • , Rakesh DixitAffiliated withMerck and Company, Inc.
  • , Lini PanditeAffiliated withGlaxoSmithKline
    • , Robert G. PietruskoAffiliated withMillenium Pharmaceuticals
    • , Holly D. SoaresAffiliated withPfizer Global Research
    • , Valerie QuarmbyAffiliated withGenetech, Inc.
    • , Ole L. VesterqvistAffiliated withBristol-Myers Squibb
    • , David M. PotterAffiliated withPfizer Global Research
    • , James L. WitliffAffiliated withUniversity of Louisville
    • , Herbert A. FritcheAffiliated withMD Anderson Hospital, University of Texas
    • , Timothy O’LearyAffiliated withFood and Drug Administration
    • , Lorah PerleeAffiliated withMolecular Staging Inc.
    • , Sunil KadamAffiliated withEli Lilly and Company
    • , John A. WagnerAffiliated withMerck and Company, Inc.

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access

No Heading

Biomarkers are increasingly used in drug development to aid scientific and clinical decisions regarding the progress of candidate and marketed therapeutics. Biomarkers can improve the understanding of diseases as well as therapeutic and off-target effects of drugs. Early implementation of biomarker strategies thus promises to reduce costs and time-to-market as drugs proceed through increasingly costly and complex clinical development programs. The 2003 American Association of Pharmaceutical Sciences/Clinical Ligand Assay Society Biomarkers Workshop (Salt Lake City, UT, USA, October 24–25, 2003) addressed key issues in biomarker research, with an emphasis on the validation and implementation of biochemical biomarker assays, covering from preclinical discovery of efficacy and toxicity biomarkers through clinical and postmarketing implementation. This summary report of the workshop focuses on the major issues discussed during presentations and open forums and noted consensus achieved among the participants on topics from nomenclature to best practices. For example, it was agreed that because reliable and accurate data provide the basis for sound decision making, biomarker assays must be validated in a manner that enables the creation of such data. The nature of biomarker measurements often precludes direct application of regulatory guidelines established for clinical diagnostics or drug bioanalysis, and future guidance on biomarker assay validation should therefore be adaptable enough that validation criteria do not stifle creative biomarker solutions.

Key Words:

biomarkers nonclinical and clinical drug development quantitative method development and validation